CNS Drug Discoveries: Depression Chapter

Date: August 22, 2008
Pages: 88
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Publisher: Espicom Business Intelligence
Report type: Strategic Report
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CNS Drug Discoveries: Depression Chapter
Depression

Antidepressants accounted for around 21% of the total CNS drug sales in 2007, with sales of US$19.4 billion. However, we anticipate that within our forecast period to 2014, the market will show negative growth as the emergence of new products is offset by the impact of generics on leading brands.

Current market leaders will launch a number of combination therapies to optimise the life-cycle management of their drugs including Eli Lilly's Symbyax. Other companies have opted to develop second-generation products to bolster their franchises such as Pristiq, a metabolite of Wyeth's Effexor. But they are only likely to offer marginal improvements over existing therapies. Meanwhile some companies will try to gain a foothold in the market by gaining approval for established products from other therapeutic areas such as AstraZeneca's schizophrenia treatment, Seroquel.

Pharmaceutical companies have also been evaluating other ways to modulate monoaminergic pathways through the agonism and antagonism of a variety of serotonin receptors such as, 5-HT1A partial agonists (MN 305 from MediciNova),

5-HT2 antagonists (valdoxan from Servier/Novartis) and even beta-3 receptor antagonists (amibegron from sanofi-aventis), as well as developing dual acting compounds which block serotonin receptors and the uptake of serotonin itself, such as Clinical Data's vilazodone.

Research into alternative targets such as CRF and NK receptors may pay off as products enter late-stage development such as sanofi-aventis' saredutant. However, there have been many casualties and it is still uncertain whether these drugs will offer any significant benefit over current therapies.

Key depression questions answered include:
  • What series of events are undermining Pfizer’s position?
  • Five new products are expected to launch by 2010 – what are they and who are their developers?
  • Sales of Wyeth’s Pristiq could reach US$1.2 billion by 2014, but what are the prospects for its generically challenged sister product Effexor in the same year?

Key products analysed and forecast

Cipralex/Lexapro - Lundbeck/Forest Laboratories
Cymbalta - Eli Lilly
Effexor - Wyeth
NS2358/GSK372475 - NeuroSearch/GlaxoSmithKline
Prozac - Eli Lilly
Paxil/Seroxat - GlaxoSmithKline
Pristiq - Wyeth
Saredutant - sanofi-aventis
Valdoxan - Novartis/Servier
Wellbutrin - GlaxoSmithKline
Zoloft - Pfizer

DEPRESSION CONTENTS

Executive Summary

THE FACTS

What is depression and why are we interested in it?
Patient Statistics
- Incidence, diagnosis rates and treatment; now and in the future
Patient Model
Drug Growth Drivers
Drug Growth Risks/Dampeners

THE MARKET

Global Antidepressant Market
Global Sales Split
- The major players and products in 2007
- The major players and products in 2014

CURRENT TREATMENTS

- Leading brands
- Current products’ patent exposure
Analysis of Leading Brands
- Selective serotonin reuptake inhibitors (SSRIs)
- Serotonin and noradrenaline reuptake inhibitors (SNRIs)
- Noradrenaline and dopamine reuptake inhibitors (NDRIs)
Global Sales Forecasts of Current Treatments 2007A - 2014E

NEW DRUGS IN R&D

Analysis of Phase lll Drugs
- Neurokinin receptor antagonists
- Melatonergic receptor agonists
- Other late-phase drugs
Global Sales Forecasts of Phase lll Antidepressant and Anti-Anxiety Drugs 2007A - 2014E
Analysis of Phase ll Drugs
- Triple uptake inhibitors
- Other Phase ll drugs of interest
Global Sales Forecasts of Phase ll Antidepressant Drugs 2007A - 2014E
Competitor Ratio Analysis - Products
Competitor Ratio Analysis - Companies
- Winners and losers
Discontinuation of Drugs

APPENDICES

- Assessment of Depression Criteria
- Phase Transition Probability
- Patient Model
- Global Antidepressant Drugs Sales 2007A - 2014E
- Competitor Ratio Analysis Criteria
DEPRESSION

EXECUTIVE SUMMARY

THE FACTS

What is depression and why are we interested in it?

PATIENT STATISTICS

Incidence, diagnosis rates and treatment; now and in the future

PATIENT MODEL

Summary of Depression Patient Population Forecasts in Seven Major Markets (2007E-2014E)
Model Assumptions

DRUG GROWTH DRIVERS

DRUG GROWTH RISKS/DAMPENERS

THE ANTIDEPRESSANT MARKET

Global CNS Market 2007 (US$91.9 billion)
Global Sales Split by Drug Class (2007A)
Global Sales Split by Region (2006)
The Major Players Products in 2007
Market Share of Antidepressant Players by Sales (Dec 2007A)
The Major Players and Products in 2014
Market Share of Antidepressant Players by Sales (Dec 2014E)

CURRENT TREATMENTS

Leading Brands
Comparison of Leading Antidepressant Drugs
Current Products' Patent Exposure
Patent Exposure of Leading Antidepressant Brands

ANALYSIS OF LEADING BRANDS

Selective Serotonin Reuptake Inhibitors (SSRIs)
Lexapro/Cipralex
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Prozac
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Seroxat/Paxil
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Zoloft
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
  Serotonin and Noradrenaline Reuptake Inhibitors (SNRIs)
Cymbalta
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Effexor
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Pristiq
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
  Noradrenaline and Dopamine Reuptake Inhibitors (NDRIs)
Wellbutrin
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis

GLOBAL SALES FORECASTS OF CURRENT TREATMENTS 2007A - 2014E

Sales Forecasts of Current Leading Antidepressant Drugs
Model Assumptions

NEW DRUGS IN R&D

Drugs in Development to Treat Depression and Anxiety Related Disorders

ANALYSIS OF PHASE III DRUGS

New Drugs in Phase III Development to Treat Depression and Anxiety
Neurokinin Receptor Antagonist
Saredutant
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
  Melatonergic Receptor Agonist
Valdoxan
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical experience
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Other Late-Phase Drugs
  Amibegron
  Seroquel
  Vilazodone

GLOBAL SALES FORECASTS OF PHASE III ANTIDEPRESSANT AND ANTI-ANXIETY DRUGS 2009E - 2014E

Sales Forecasts of Phase III Developmental Drugs for Depression and Anxiety
Model Assumptions

ANALYSIS OF PHASE II DRUGS

New Drugs in Early Clinical Development to Treat Depression and Anxiety
Triple Uptake Inhibitor
NS2359
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Other Phase II Drugs of Interest
  DOV 21,947
  MN-305

GLOBAL SALES FORECASTS OF PHASE II ANTIDEPRESSANT DRUGS 2010E - 2014E

Sales Forecasts of Phase II Developmental Antidepressant Drugs
Model Assumptions

COMPETITOR RATIO ANALYSIS

COMPETITOR RATIO ANALYSIS - PRODUCTS

CR Analysis of Antidepressant Agents Approved by 2014 - Based on Drug Class

COMPETITOR RATIO ANALYSIS - COMPANIES

CR Analysis of Antidepressant Agents Approved by 2014 - Based on Company

WINNERS & LOSERS

Summary of Key Companies and Drugs in the Antidepressant Market by 2014
Winners
Losers

DISCONTINUATION OF DRUGS

Antidepressants/Anxiolytics Discontinued from Clinical Development

DEPRESSION APPENDIX 1

ASSESSMENT OF DEPRESSION CRITERIA

DEPRESSION APPENDIX 2

PHASE TRANSITION PROBABILITY

Probability of Launch

DEPRESSION APPENDIX 3

Patient Model
Summary of US Depression and Anxiety Patient Population Forecasts
Summary of Europe (Top 5) Depression and Anxiety Patient Population Forecasts
Summary of Japanese Depression and Anxiety Patient Population Forecasts

DEPRESSION APPENDIX 4

GLOBAL ANTIDEPRESSANT DRUGS SALES 2007A-20014E

DEPRESSION APPENDIX 5

COMPETITOR RATIO ANALYSIS CRITERIA

Key Antidepressant/Anxiolytic Drugs on the Market by 2014

DEPRESSION GLOSSARY

DEPRESSION REFERENCES

ACRONYMS
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